Search results for "manufacturing" in Articles / App Notes
Article
Automating the Biomanufacturing Process
Automation has traditionally focused on controlling the manufacturing process throughout production to ensure that product remains identical between batches. Control has been manifested mainly in mini…
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Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …
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The Challenge of Disruptive Technologies in Bioprocessing
… growing R&D expenditure in biopharma companies are factors driving the growth of the global biomanufacturing industry, including downstream bioprocessing,” adds Orjana Terova, product manager, downs…
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Making the Move to Continuous Chromatography
“Multicolumn chromatography has long been an accepted continuous purification practice by small-molecule manufacturers, but is just now gaining traction in the biomanufacturing space,” he says.
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
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Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…
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Re-use of Protein A Resin: Fouling and Economics
Figure 1: Pie chart illustrating type of Protein A media used for monoclonal antibodies/Fc-fusion protein manufacturing.
Number of cycles
As discussed previously, biotech manufacturers typical…
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Viral Clearance Challenges in Bioprocessing
Upstream viral clearance
Using media with a low level of viral contamination can lead to major problems in biologics manufacturing. Cell-culture media and other raw materials, particularly those de…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
There were no benefits or need for platform development or expanding manufacturing capabilities. Cell culture was performed using numerous methods, including roller bottles and stirred tank bioreactor…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
…, and manufacture medical products—and revised regulatory practices for evaluating clinical data, manufacturing operations, and procedures for submitting and analyzing information.
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